Status unknownNCT02031263Updated Aug 19, 2014

Efficacy of Bronchial Thermoplasty in Korean

A Phase 4 interventional study of bronchial thermoplasty system in Asthma, sponsored by Asan Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-19.

Sponsored by Asan Medical Center · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2014), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 4
Study type: Interventional
Enrollment: 9
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

The investigators will find out if bronchial thermoplasty shows efficacy in reducing acute exacerbation and improving quality of life for uncontrolled asthma in Korea through this research. US FDA approved this procedure and CE mark was taken in Europe. Many procedure was performed in Western countries.

Korean FDA have approved this procedure in 2013. However, no procedure was performed in Korea, and the data is rare in Asian countries. In this study, investigators will examine the efficacy of this procedure in Korean asthmatics.

Conditions studied

Asthma

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Asthma 3,921

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 9 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

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Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

1. Eighteen-year-old or older
1. Patients whose asthma is not controlled with more than three months of using high dose inhaled steroids and long acting β2-agonists
1. Patients with pre-bronchodilator FEV1 is between sixty and eighty-five%
1. Patients who do not improve through continuous drug uses.

Exclusion criteria

Exclusion Criteria:

1. Presence of a pacemaker, internal defibrillator, or other implantable electronic devices,
1. Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine, and benzodiazepines.
1. Patients previously treated with the Alair System should not be retreated in the same area(s). No clinical data are available studying the safety and/or effectiveness of repeat treatments.
4)Active respiratory infection
1. Asthma exacerbation or changing dose of systemic corticosteroids for asthma (up or down) in the past 14 days.
1. Known coagulopathy.
1. As with other bronchoscopic procedures, patients should stop taking anticoagulants, antiplatelet agents, aspirin and NSAIDS before the procedure with physician guidance.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 9 participants (estimated)

Study arms

Experimental
thermoplasty group
Check on the quality of life, emergency room uses, and sudden progress of the disease of the patients before and after the treatment by using bronchial thermoplasty system by using paired t test.
Procedure: bronchial thermoplasty system

Interventions

Procedurebronchial thermoplasty system
Check on the quality of life, emergency room uses, and sudden progress of the disease of the patients before and after the treatment by using bronchial thermoplasty system by using paired t test.
Also known as: ALAIR

What researchers measure

Primary outcomes

Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA
Time frame: 3 months

Secondary outcomes

Quality of Life Questionnaire for Adult Korean Ashtmatics - QLQAKA Questionnaire for Adult Korean Ashtmatics - QLQAKA
Time frame: 6 months
Acute exacerbation
Acute exacerbation of asthma is defined as following: episodes of progressive increase in shortness of breath, cough, wheezing, or chest tightness, or some combination of these symptoms leading change of medications (use of systemic steroids or antibiotics)
Time frame: 3,and 6 months

Study locations

1 of 1 sites recruiting

Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine
Seoul, 138-736, Korea, Republic of
- Sei Won Lee, MD · Contact · iseiwon@gmail.com · +82-2-3010-3990
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02031263
Lead sponsor: Asan Medical Center
Responsible party: Sei Won Lee (Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine, Asan Medical Center) — Principal investigator
First posted: Jan 9, 2014
Start date: Feb 2014
Primary completion: Feb 2015 (estimated)
Completion: Feb 2015 (estimated)
Last update: Aug 19, 2014

Study contacts

Sei Won Lee, MD

Contact

iseiwon@gmail.com

+82-2-3010-3990

Sei Won Lee, MD

principal investigator · Department of Pulmonary and Critical Care Medicine and Clinical Research Center for Chronic Obstructive Airway Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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